Study comparing NVL-655 to alectinib in untreated patients with ALK-positive advanced non-small cell lung cancer

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What is this study about?

This study focuses on patients with advanced non-small cell lung cancer (NSCLC) that is ALK-positive. ALK-positive means the cancer has a specific genetic change in the anaplastic lymphoma kinase gene. The study compares two medications: an experimental drug called NVL-655 and an approved medication called Alecensa (alectinib). These medications belong to a group of drugs called ALK inhibitors, which target the specific genetic change found in this type of lung cancer.

The purpose of this research is to evaluate how well NVL-655 works compared to Alecensa in patients who have not received any previous treatment for their advanced lung cancer. Both medications are taken by mouth in the form of tablets or capsules. The study will measure how long patients live without their cancer getting worse and track any side effects that may occur during treatment.

During the study, participants will be randomly assigned to receive either NVL-655 or Alecensa. The treatment may continue for up to several years, depending on how well it works for each patient. Throughout the study, patients will have regular medical check-ups and imaging scans to monitor their cancer. The study will also look at how the treatments affect patients’ quality of life and whether the medications work on cancer that has spread to the brain.

1 Initial assessment

Your eligibility for the study will be confirmed through medical tests showing non-small cell lung cancer (NSCLC) that is locally advanced or has spread to other parts of the body

A test will confirm the presence of ALK gene rearrangement in your tissue or blood sample

Your doctor will verify that you have not received any prior systemic treatment for NSCLC

A tissue sample from your tumor will be required (either existing or new)

Your physical condition will be evaluated using the ECOG scale (a measure of daily living abilities)

2 Treatment assignment

You will be randomly assigned to receive either NVL-655 tablets or Alecensa capsules (alectinib)

Both medications are taken by mouth

The exact dosing schedule will be provided by your healthcare team

3 Regular monitoring

Your cancer progression will be regularly assessed through imaging scans

Your response to treatment will be evaluated using standardized criteria

Blood tests will be performed to monitor your health

You will complete questionnaires about your health and symptoms

Any side effects will be monitored and recorded

4 Treatment duration

Treatment will continue until your disease progresses

Treatment may also be stopped if unacceptable side effects occur

The study is planned to run until October 2029

Who Can Join the Study?

  • Must have confirmed advanced or metastatic non-small cell lung cancer (cancer that has spread and cannot be treated with combined therapies)
  • Must have a positive test for ALK gene rearrangement (a specific genetic change in the cancer cells) from either tissue or blood sample
  • Must not have received any previous systemic treatment for lung cancer, except:
    • May have had chemotherapy before or after surgery if it was completed at least 12 months before study entry
    • Must never have received ALK inhibitor drugs (like alectinib) at any time
  • Must have at least one tumor that can be measured using standard imaging techniques
  • Must be able to provide a tumor tissue sample (either previously collected or from a new biopsy)
  • Must have good physical function ability, rated as ECOG 0-2 (able to care for self and be up and about more than half of waking hours)
  • Must be an adult (18 years or older)
  • Can be either male or female

Who Cannot Join the Study?

  • Age under 18 years
  • History of treatment with any ALK inhibitor (medications that target ALK-positive lung cancer)
  • Active brain metastases (cancer that has spread to the brain) that are not stable or require steroids
  • History of other cancers within the past 3 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
  • Significant heart problems, including:
    • Uncontrolled high blood pressure
    • Heart attack within past 6 months
    • Unstable heart rhythm disorders
  • Severe liver problems or abnormal liver function tests
  • Known HIV infection, active hepatitis B, or active hepatitis C
  • Any serious medical condition that could interfere with study participation
  • Pregnant or breastfeeding women
  • Unable to swallow oral medications
  • Participation in another clinical trial within 28 days before starting this study

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
IRCCS Humanitas Research Hospital Rozzano Italy
Medizinische Universitaet Innsbruck Innsbruck Austria
Institut Gustave Roussy Villejuif France
Katholieke Universiteit te Leuven Leuven Belgium
Athens Medical Center S.A. Athens Greece

Other Sites

Site Name City Country Status
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Klinikum Esslingen GmbH Esslingen Am Neckar Germany
Ospedale S G Moscati Statte Italy
Centre Francois Baclesse Caen France
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
LungenClinic Grosshansdorf GmbH Grosshansdorf Germany
Wiener Gesundheitsverbund Vienna Austria
Cygutzcpk Uzoweegaminepr Sezdjyakt Woluwe-Saint-Lambert Belgium
Gmfzfcq Urfhjivefo Hiaefkwx Of Lyyiyil Larissa Greece
Uwncmkdhwe Oc Dhcbmrnp Debrecen Hungary
Lzxuf Gnrnfla Haurftkk Ox Apykxc Athens Greece
Hptbasmb Ugtzihzqschbq dz A Crcwdt A Coruna Galicia Spain
Vtffxr dhg Rxgyb Ucepgxkecr Hjadrpon Sevilla Spain
Octahe Utpdczkxrh Htlkljhv Odense Denmark
Hbvimq Hvpakcro Herlev Denmark
Itpvlqqz Rkepplruo Phi Lm Suyeud Dyc Tnhies Dhkh Arbtkqf Ibwz Swojum Meldola Italy
Aomqphbhid Poxwnfwy Hpifmroj Du Mhklvbemp Marseille France
Uyqzjjwhfscb Mrxarhn Cnlbgce Ugzvkml Utrecht The Netherlands
Udoxviqqpcanrfnjl Plkwutkgboo Dklmx Mvfhpk Ancona Italy
Nasinnrxm Alam Naam Jttsz ajes Novy Jicin Czechia
Knebbjly dyu Ucezpwwfwtuv Msqztjfr Avt Munich Germany
Ulegssfuauyoav Cqgzgms Kcgqmddmf Gdansk Poland
Cuinwi Lvuo Bkrwdc Lyon France
Uvekylfzji Or Asemcsd Edegem Belgium
Iukumf Ieddnghz Fetljgvoierzt Owuwmfdrqqz Rome Italy
Hqmlqjln Uvjmoqrpoinsv 1c Di Oqwlnax Madrid Spain
Ijorcgrd Ccgpij Dskegeilrqkdjahoa L'hospitalet De Llobregat Spain
Ctjmge Hzhwfkmsxwr Rvindnds Dsmhnpjtfsxyan Angers France
Iymqphxy Tthive Bxxh Gezfinfb Punlb If Bari Italy
Fqgahqybhp Ishla Svj Gyqqtte Dmq Tlvxhsi Monza Italy
Fvnucotyaa Iflfhrpnwx Ikkcmoko Nqiiarbugua Bzpwb Milan Italy
Hfuppovk Cty Posag Sefb Porto Portugal
Almkxrc Oysiziyktvy Ustcowzrmosaw Pcbpgk Pisa Italy
Iyzxdjpp Oqyqeaicow Vizaod Padua Italy
Iclrmlfl Rbeoqhrp Dh Cteclr Dw Mzegidwtdze Montpellier France
Muxtaenrl svllvc Horovice Czechia
Becswyinryp Vxezizoty Ogautdpczzht Kecskemet Hungary
Mumtrf Glimypadjmhz Gyongyos Hungary
Zyproqr Mplucel Cefydh Suy z orrt Lublin Poland
Gbuczbw Mhuie Iimlwbuc Kenwhvw Gwgsrtrp Adsm Mpuhjfkqa Gvcasunaywacp Cltkhqvteifd Thessaloniki Greece
Idyjwqul Dp Cvnrwkuy Fwwynwmpsq Dpo Ptqkdbbd Pgv Liovnmqlls Iftjt Candiolo Italy
Cipsthzvokpt Ctmaikdb Cbqaeo Lisbon Portugal
Ghln Suniq Prcaddpxs Cgihium Smty Cascais Portugal
Nhimayhggdq Ceojuz Iefzcciqc Amsterdam The Netherlands
Huwjlo Kmbnxlcg Ewry vrg Buahwpb Gjsc Berlin Germany
Slwqgpn Snelzaqbzpslhrp W Bezkanavb Pbrscschjbu Oixvvcs Outmypjuaphu Ilgidjwuypmbtpmmtmh Brzozow Poland
Mhulqkms Chrfck Szuhem Barcelona Spain
Oxj Dhz Mki Spg z ohot Szczecin Poland
Mvbjkcckjirvl Vbfhdps Gut Velbert Germany
Htktj Dduqab Hrybpivs Cbaonx Athens Greece
Lglykxxiajlqnrns Ijloawblhlx Immenhausen Germany
Cikmvj Hqoekojnihm Uvwxnknyhvkhq Dn Nlwlsx Saint-Herblain France
Avrusaorlj Pqbhshlf Hyysukfd Dj Pwkdi Paris France
Cyoske Hphjbrmgaxi Uikqpxqgopflf Dv Tholiimr Toulouse France
Srsjogdwr Rifonin Uwerivbmag Msnlkph Clescl Nijmegen The Netherlands
Apdbkg Uhreougkmy Hiyohgyd Aarhus Denmark
Aefvghu Ulyea Syqwskpgb Lswraz Dwrpy Rvcxuqt Ravenna Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
15.11.2025
Belgium Belgium
Recruiting
15.11.2025
Czechia Czechia
Recruiting
15.11.2025
Denmark Denmark
Recruiting
15.11.2025
France France
Recruiting
15.11.2025
Germany Germany
Recruiting
15.11.2025
Greece Greece
Recruiting
15.11.2025
Hungary Hungary
Recruiting
15.11.2025
Italy Italy
Recruiting
15.11.2025
Poland Poland
Recruiting
15.11.2025
Portugal Portugal
Recruiting
15.11.2025
Spain Spain
Recruiting
15.11.2025
The Netherlands The Netherlands
Recruiting
15.11.2025

Trial locations

NVL-655 is a new selective Anaplastic Lymphoma Kinase (ALK) inhibitor. It is being studied as a treatment for advanced non-small cell lung cancer in patients who have not received previous treatment. This medication works by targeting specific proteins that are involved in cancer cell growth.

Alectinib is an established ALK inhibitor medication used to treat non-small cell lung cancer. It works by blocking specific signals that cancer cells use to grow and spread. It is currently used as a standard treatment for patients with ALK-positive lung cancer.

Non-small cell lung cancer (NSCLC) – A type of lung cancer that begins in the cells of the lungs and forms in the tissues of the lung, typically in the cells lining air passages. It develops when healthy cells in the lung change and grow out of control, forming a mass called a tumor. NSCLC specifically refers to several types of lung cancers that behave in similar ways, with the ALK-positive variant being characterized by a specific genetic change in the anaplastic lymphoma kinase (ALK) gene. The disease can spread from its original location to other parts of the body through the blood or lymph system. As the cancer progresses, it may affect breathing and other bodily functions.

Trial ID:
2024-517553-26-00
Protocol code:
NVL-655-04
NCT ID:
NCT06765109
Trial Phase:
Therapeutic confirmatory (Phase III)

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